Depovit B12 Ampoules – Hydroxocobalamin

Company Name: Amriya for Pharmaceuticals Industries

Trade Name: Depovit B12, Ampoules

Generic Name: Hydroxocobalamin

Composition: Each 1 ml ampoule contains:

  • Active ingredient:
    • Hydroxocobalamin acetate 1.20 mg (Equivalent to Hydroxocobalamin… 1000 µg/ml)
  • Inactive ingredients:
    • Sodium dihydrogen phosphate
    • Water for injections

Pharmaceutical Form: Ampoules

Pharmacology: Depovit B12, Ampoules contain hydroxocobalamin, a stable form of vitamin B with prolonged action. It provides a continuous supply of vitamin B to replenish body stores, correcting and preventing vitamin B deficiency. Vitamin B acts as a coenzyme for various metabolic functions, including metabolism of fats, carbohydrates, and protein synthesis. It plays important roles in growth, cell reproduction, blood formation, and genetic material synthesis. Deficiency can lead to megaloblastic anemia and nerve damage. Depovit B12 results in rapid improvement in blood and nerve health, as well as overall well-being.

Depovit B 12 Ampoules are safe and well-tolerated, causing no pain or irritation at the injection site.

Pharmacokinetics: Depovit B12 Ampoules are well absorbed when injected into muscles. It binds to plasma proteins and is stored in the liver, excreted in bile, and recirculated. It crosses the placenta and appears in breast milk.

Indications:

  • Treatment and prevention of vitamin B deficiency in conditions such as:
    • Pernicious and megaloblastic anemia
    • Post-gastrectomy or ileal resection
    • Gastric atrophy or lesions affecting the intrinsic factor
    • Congenital cobalamin malabsorption
    • Strict vegetarians
    • Tobacco amblyopia
    • Infection with intestinal parasites or bacteria
  • Increased requirements of vitamin B in conditions like:
    • Hemolytic anemia and hemorrhage
    • Thyrotoxicosis and malignancy
    • Hepatic and renal diseases
    • Cyanide toxicity associated with sodium nitroprusside
    • Nervous manifestations and neurological disorders

Dosage:

  • For anemia and severe deficiencies: 1 ampoule (I.M.) every other day for 1-2 weeks, then 1 ampoule every 3 months for maintenance.
  • For neurological cases: 1 ampoule (I.M.) every other day until improvement is optimum.
  • For prophylactic use in anemia and mild deficiencies: 1 ampoule (I.M.) every 2-3 months.

Contraindications: Hypersensitivity to hydroxocobalamin or cobalt.

Side Effects: Depovit B12 is well tolerated, but rare hypersensitivity reactions may include itching, diarrhea, urticaria, or peripheral vascular thrombosis.

Drug Interactions: Chloramphenicol may interfere with the therapeutic response to hydroxocobalamin injection.

Precautions and Warnings: Hypokalemia may occur during initial treatment of severe megaloblastic anemia. Vitamin B therapy may unmask signs of polycythemia vera.

Package: A carton box containing 3 or 5 ampoules (amber glass, type I), each of 1 ml + pamphlet.

Storage: Store at temperatures not exceeding 30 °C.

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